The purpose of this study is to see if it is effective to treat children with anxiety disorders with fluvoxamine. Fluvoxamine has been successfully used to treat obsessive-compulsive disorder (OCD) in adults and children. Anxiety disorders other than OCD, such as generalized anxiety disorder, social phobia, or separation anxiety, are very common in youth and are not always responsive to...
Date First Received: November 2, 1999
Last Updated: June 13, 2007
Verified by: National Institute of Mental Health (NIMH), November 2005
Clinical Trial Phase: Phase 3 | Start Date: October 1996
Overall Status: Completed
Brief Summary
Official Title: “Research Unit on Pediatric Psychopharmacology Anxiety Treatment Study”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to see if it is effective to treat children with anxiety disorders with fluvoxamine.
Fluvoxamine has been successfully used to treat obsessive-compulsive disorder (OCD) in adults and children. Anxiety disorders other than OCD, such as generalized anxiety disorder, social phobia, or separation anxiety, are very common in youth and are not always responsive to behavioral therapies alone. These disorders may respond to fluvoxamine.
A child will be evaluated for 3 weeks before he/she is assigned randomly (like tossing a coin) to receive either fluvoxamine or an inactive placebo for 8 weeks. After this double-blind phase (neither the child/parents nor the doctor know which treatment is being given), the child will have the option of continuing treatment during a 4-month open-label extension period (both the child/parents and the doctor know which the child is receiving).
A child may be eligible for this study if he/she:
Is 6 to 17 years old and has been diagnosed with an anxiety disorder (i.e., generalized anxiety disorder, social phobia, or separation anxiety).
Study Type: Interventional
Study Design: Treatment, Double-Blind, Placebo Control
Detailed Clinical Trial Description
To evaluate fluvoxamine in the treatment of children and adolescents with anxiety disorders.
Fluvoxamine is a serotonin reuptake inhibitor that is FDA-approved for the treatment of obsessive-compulsive disorder (OCD) in adults and children. Anxiety disorders other than OCD are very common in youth and are not always responsive to psychosocial therapies. Fluvoxamine is an alternative treatment.
After a 3-week period of evaluation, patients meeting study entry criteria are randomized to receive either fluvoxamine or placebo for 8 weeks. After this double-blind phase, patients can enter a 4-month open-label extension.
Intervention(s) in this Clinical Trial
- Drug: Fluvoxamine
Criteria for Participation in this Clinical Trial
- Patients must have: DSM -IV diagnosis of generalized anxiety disorder, social phobia, or separation anxiety.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 6 Years
Maximum Age for this Clinical Trial: 17 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: National Institute of Mental Health (NIMH)
Overall Clinical Trial Officials and Contacts
Laurence Greenhill, MD Principal Investigator
Related Publications
References
[No authors listed] Fluvoxamine for the treatment of anxiety disorders in children and adolescents. The Research Unit on Pediatric Psychopharmacology Anxiety Study Group. N Engl J Med. 2001 Apr 26;344(17):1279-85.
Coyle JT. Drug treatment of anxiety disorders in children. N Engl J Med. 2001 Apr 26;344(17):1326-7. No abstract available.
Additional Information
Information obtained from ClinicalTrials.gov on January 06, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00000389
Study ID Number: N01 MH60005
ClinicalTrials.gov Identifier: NCT00000389
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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